Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW)

Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW) Multistate Pharmacy Jurisprudence Exam (MPJE) Review (FEDERAL LAW) Food and Drug Administration Correct Answer: a federal agency in the Department of Health and Human Services established to regulate the release of new foods and health-related products (P)FDA Correct Answer: Pure Food and Drug Act of 1906 Federal Food, Drug, and Cosmetic Act of 1938 (6/25/38) Correct Answer: FDCA Poison Prevention Packaging Act of 1970 Correct Answer: PPPA Controlled Substance of 1970 Correct Answer: CSA Controlled Substance Act of 1970 Correct Answer: What act established the FDA in 1970? DEA (created 1973) Correct Answer: Drug Enforcement Administration Prescription Drug Marketing Act of 1987 Correct Answer: PDMA Omnibus Budget Reconciliation Act of 1990 Correct Answer: OBRA 90 - what does it stand for Adulteration Misbranding Placing into interstate commerce unapproved new drugs Correct Answer: What 3 illegal acts did the Pure Food and Drug Act of 1906 establish Federal Food, Drug, and Cosmetic Act of 1938 Correct Answer: Mandated tests for drug toxicity and provided means for recall of drugs; established procedures for introducing new drugs; gave FDA the power of enforcement Intended Use Correct Answer: A drug is dependent on _____________ Provider, not the user Correct Answer: Intended use is determined by the___________, not the __________ 1. In USP, or NF, or Homeopathic P. 2. Articles INTENDED FOR use in the Diagnosis Cure Mitigation Treatment or Prevention of Disease in man or animal 3. Articles intended to affect the STRUCTURE or FUNCTION of the body (other than food) 4. Any component of the above Correct Answer: Drug Device Correct Answer: Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent A drug works through a chemical reaction and is dependent on metabolism. ; Devices are only recognized in the USP or NF (Not homeopathic) Correct Answer: What is the difference between how a drug works and a device works I. Reasonable assurance of safety and effectiveness (referred to as GENERAL CONTROLS device) II. Insufficient info for reasonable assurance safety and effectiveness III. Pre-market approval Correct Answer: What are the 3 classes of devices Class I Correct Answer: Device class - Reasonable assurance of safety and effectivenss Class III Correct Answer: Pre-market approval cosmetic Correct Answer: Something applied to the body for Cleansing, Beauty, Altering, Appearance. (NOT SOAP) True Correct Answer: True or False: A item can be both a drug AND cosmetic Label Correct Answer: Written, printed, or graphic on the container or accompanying it Label Correct Answer: What must always accompany the container because it conveys intended use True Correct Answer: True or False: A patient may be given a package insert FDA Correct Answer: Labelling must be ________ approved Contraindications Warnings Precautions Adverse Reactions Correct Answer: What is the order of importance of what is included in a package insert Essential scientific information; not false or promotional evidence of safe and effective clinical pharmacology Correct Answer: What is the required content of a package insert New Drug Correct Answer: Any drug after June 25, 1938 that was subject to the Food and Drug Act of 1906 NDA (New Drug Application Correct Answer: Required of all new drugs ANDA (Abbreviated New Drug Application) Correct Answer: Required of all generic drugs Same: Entity Strength Dosage Form And MUST BE BIOEQUIVALENT Correct Answer: What are the requirements of an ANDA False - just new drugs (prior to interstate commerce) Correct Answer: True or False: Both new drugs and generic drugs must be proven to be safe and effective Adulterated Correct Answer: What a drug is corrupt, debase or made impure by the addition of a foreign or inferior substance or element Misbranding Correct Answer: Label is false or misleading (no label or a false label) Rx only Correct Answer: Caution: Federal law prohibits dispensing without a prescription. (FEDERAL LEGEND) True Correct Answer: True or False: a filled prescription is exempt from misbranding if the drugs has "Federal Legend" and is properly filled Misbranding Correct Answer: Dispensing a prescription without prescription is considered_________ GRAE (generally recognized as effective) GRAS (generally recognized as safe) Correct Answer: New drugs must be Class I Correct Answer: Device class also referred to as General Controls The intentions of drugs or devices: Diagnosis Cure Mitigation Treatment or Prevention of disease in man or animal Correct Answer: What acronym is Doc My Toes are Purple for? 1. Lack of safety without supervision 2. Sponsor's request Correct Answer: What are two ways for an item to be classified as prescription 1. Call your doctor 2. Call FDA at 1-800-FDA-1088 3. Report online at FDA Adverse Event Reporting System (FAERS) Correct Answer: -database on adverse events and med error reports given to FDA -info used to ID possible safety concerns -manufacturers who receive adverse drug event report must submit info to FDA FDA Recall Class I Correct Answer: Threat to LIfe (what FDA Recall Class) FDA Recall Class II Correct Answer: Temporary or reversible adverse health consequences (what FDA Recall Class) FDA Recall Class III Correct Answer: Not likely to have adverse health consequences (what FDA Recall Class) Class III Correct Answer: What FDA recall class is the most common recall True Correct Answer: True or False: FDA recalls may be conducted on a firm's own initiative by FDA request, Or by FDA order under statutory authority False Correct Answer: A lot number or the National Drug Code is required by law to be put on the manufacturer's container There are no federal requirements regarding product expiration Correct Answer: What is the federal requirement for an expiration date on products that are extremely stable? 2 years from the date of manufacture Correct Answer: What is the proper expiration date on insulin 6 months OR 25% of the time remaining from date of repackaging to manufacturers expiration date, whichever is sooner/less Correct Answer: What is the proper expiration date when repackaging medications in unit-doses? FDCA of 1938 Correct Answer: What act mandates that any new drug must be proved safe and label must include directions for use and warnings? And has to do with recalls, NDC numbers, etc Kefauver-Harris Amendments Correct Answer: What law required prescription medications manufactured between 1938 and 1962 to be effective Phase III Correct Answer: In drug development, in what phase of testing is the largest, involves humans, and gathers data on safety and efficacy Phase IV Correct Answer: In what phase are LONG TERM safety and efficacy are established post marketing approval Drug monograph Correct Answer: What process is used to describe the FDA panel review of ingredients for OTC products to determine safety and efficacy, indications, instructions and warnings? Dietary supplements Correct Answer: Do not require pre-marketing approval Diet supplement; drug Correct Answer: The source of the item determines if an item is a _______ ___________ or a ____________ 30 days Correct Answer: Unless it makes a therapeutic claim, the FDA must be notified no later than _______ after first marketing Vitamin Mineral Herb or Botanical Amino acid Substance used to supplement diet Any component or metabolite Correct Answer: What are the types of dietary supplements Statement on a label Correct Answer: If it has a structure/function claim, it must have a __________________ "This supplement has not been approved by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease Correct Answer: What statement is on a dietary supplement label A therapeutic claim Correct Answer: What is not allowed on a dietary supplement FDA Orange Book Correct Answer: Generic equivalency book, A# is interchangable, shows drugs which are approved drug products with therapeutic equivalency evaluations Equivalent; not equivalent Correct Answer: In the Orange book, A means ________________ and B means ___________________ Pregnancy Category A Correct Answer: Safe in studies of pregnant women Pregnancy Category B Correct Answer: Safe in studies of animals (NO HUMAN STUDIES) Pregnancy Category C Correct Answer: Unsafe in animals; no human studies and therapeutic effect outweighs potential risk Pregnancy category D Correct Answer: Unsafe in HUMAN studies but therapeutic effect outweighs potential risk Pregnancy category X Correct Answer: Unsafe in human studies; RISK outweighs potential benefits June 1, 1999 Correct Answer: Medication guides were mandated by the FDA Lotronex Estrogens Progestational drugs Oral contraceptives Correct Answer: What drugs are required by be dispensed with a medication guide 1. Clear English, non-technical language 2. Label heading "Medication Guide" 3. Brand name and generic name immediately under heading 4. Consistent with package and insert 5. TEXT IS 12 POINT FONT 6. Boxes, bold, underlining, and highlight important information 7. Must say at the bottom "This medication guide has been approved by the Food and Drug Administration Correct Answer: Describe the medication guide (7 things) 12 point font Correct Answer: The size of the text on a medication guide is a Ipecac syrup Correct Answer: An example of an OTC medication requiring special labeling Isoproterenol inhaled products and thyroid hormones Correct Answer: Examples of prescription medications requiring special labeling True Correct Answer: True or false: The medication guide must be based on approved professional labeling Misbranding Correct Answer: Pharmacists who do not give out mandated medication guidelines are guilty of Drug name Manufacturer Indicated use Contraindications Description of serious risks Other side effects Instructions for use Date of revision Correct Answer: The patient package insert for estrogen products shall contain (8 things) False Correct Answer: True or false: Estrogen-progesterone oral contraceptives must contain the required items on the patient package insert Tablet ID Correct Answer: All solid dosage forms shall have a code imprint that provides unique identification Symbol, logo, monogram, mark Correct Answer: What are the permissible components which can be included as ID on a tablet homeopathic drugs Correct Answer: Which drugs only have to have to identify the manufacturer or the nature of the drug Adulterated AND misbranded Correct Answer: If there is no tablet ID, then it is considered to be __________________________ NDA or use Drug monograph Correct Answer: What are two ways to bring an OTC to the market Prescription Drug Marketing Act of 1987 Correct Answer: Prevents re-importation of a drug into US Prohibited hospital and healthcare entities from reselling their pharamaceuticals 1. Cant buy, sell or trade samples 2. Cant buy, sell or trade drugs purchased by a hospital or health care facility 3. Cant buy, sell or trade drugs sold to charitable organizations Correct Answer: What are the 3 provisions of the Prescription Drug Marketing Act of 1987 1. Written request, or 2. Written receipt Correct Answer: Samples may only be given only with a No Correct Answer: Are pharmacists allowed to have samples in their retail pharmacy Yes Correct Answer: Can hospital pharmacies have samples in the pharmacy 1. Hospital pharmacies may store samples provided they are kept separate 2. Hospitals MUST keep copies of prescribers' written requests to pharmaceutical companies requesting samples 3. They may not sell these samples Correct Answer: Under the PDMA of 1987, what is permissible regarding hospital pharmacies and samples Yes Correct Answer: Per the PDMA, are drug wholesalers required to register in each and every state in which they operate No, it is dispensing Correct Answer: Is reconstitution compounding? If not, what is it Pharmacists could not advertise specific drug compounds that they made, only that they compounded Correct Answer: Before 2002, what could pharmacists advertise about compounding Pharmacists have since then been able to advertise specific compounded drugs Correct Answer: Since 2002, the Supreme Court overruled the FDAs law on what pharmacists could and could not advertise and said it was unconstitutional. So pharmacists have been able to do what Poison Prevention Packaging Act of 1970 Correct Answer: What does the PPPA stand for Mandated child resistant closures Correct Answer: The Poison Prevention Marketing Act of 1970 did what Prescription drugs for oral use (with exceptions) and some, but not all, OTCs Correct Answer: What products are mandated for tamper resistant packaging Only the DOCTOR and the PATIENT Correct Answer: Who can request NON-child resistant closures No blanket orders allowed, the doctor MUST SPECIFY on each Rx Correct Answer: How does the doctor specify not to dispense prescription drugs in child-resistant closures CPSC (Consumer Product Safety Commission) Correct Answer: Who enforces the PPPA of 1970 New plastic prescription containers Correct Answer: What does the PPPA of 1970 require with each prescription refill "This package for households without young children" Correct Answer: What labeling must be on a single size OTC exempted from the child-resistant principle of the PPPA of 1970 NTG sublingual Isosorbide (SL or chewable) EES granules in oral solution Oral contraceptives in mfr dispensed packages Unit dose forms Sodium fluoride Betamethasone Pancrelipase tablets Prednisone Mebendazole Methylprednisolone Colestipol EES tablets Conjugated estrogens in dispenser packaging Norethindrone in dispenser packaging Medroxyprogesterone Sacrosidase Correct Answer: What are some exceptions to mandated child resistant closures The Medicaid law Correct Answer: What is OBRA 1990 another name for Mandated drug regimen review Correct Answer: What did OBRA 1990 establish Prospective and retrospective ("ProDUR and RetroDUR) Correct Answer: What types of Drug Utilization Reviews are required by OBRA 1990 Screening for therapeutic duplication Drug-disease contraindication Drug-drug interaction Incorrect drug dosage or duration of drug treatment Clinical abuse Correct Answer: What are examples of items screened for in prospective Drug Utilization Review AHFS Drug Points (FORMERLY USP-DI) DrugDex AMA drug evaluation Correct Answer: Drug regimen review is based on Pharmacists must offer to consult Correct Answer: What was the jist of OBRA 1990 that you remember from school Retrospective Drug Utilization Review Correct Answer: Examines history of mediation Utilization to identify certain patterns using patient profiles; looking for things like proper use, drug interactions, and compliance. Then notify doctors and pharmacists about problems to be corrected. Medicaid patients with new prescriptions only Correct Answer: According to OBRA 90, the pharmacist must offer to counsel the patient. Who is covered by this requirement? 1. Telephone communication with the patient 2. A toll free telephone number 3. A sign posted informing customers of their right to counseling Correct Answer: What individual acts constitute a legal offer to counsel Corresponding liability Correct Answer: If a patient injury results from a wrong dosage, and prior to dispensing you noticed it and called the physician who told you to fill it as written, what kind of liability do you have Controlled Substance Act of 1970 Correct Answer: What does CSA stand for The DEA Correct Answer: The CSA established the ____ 1. To prevent diversion and abuse of these drugs 2. While ensuring an adequate and uninterrupted supply is available to meet the country's legitimate medical, scientific and research needs Correct Answer: What is the two-fold responsibility of the DEA Closed system Correct Answer: The type of distribution that all controlled substances must fall within, established by Congress Manufacturers Distributors Physicians Pharmacies Researchers Correct Answer: Examples of legitimate handlers of controlled substances under the CSA of 1970 controlled substances Correct Answer: A drug, other substance, or immediate precursor, which is regulated by the CSA because it has a potential for abuse A. The Attorney General has designated to be the principal compound used, or produced primarily for use, in manufacture of a controlled substance; B. Is an immediate chemical intermediary used or likely to be used in the manufacture of such controlled substance; AND C. The control of which is necessary to prevent, curtail, or limit the manufacture of such controlled substance Correct Answer: "Immediate Precursor" means a Substance: (3 things) 1. Are individuals taking the drug in amounts sufficient to create a hazard to their health or to the safety of others or to the community? 2. Is there significant diversion of the drug from legitimate drug channels? 3. Are individuals taking the drug on their own initiative rather than on basis if legitimate medical advice? 4. Is the drug a new drug that is related in its action to a drug, already listed as having a potential for abuse to make it likely that the drug will have the same potential for abuse as such drugs? Correct Answer: In determining whether a drug or other substance has potential for abuse, the DEA considers 4 factors: Habitual use of narcotics Correct Answer: What is the definition of an addict practitioner Correct Answer: Physician, dentist, vet, scientific investigator, pharmacist, hospital, other person licensed and registered (or specifically a pharmacy) to distribute, dispense, administer or clinically supervise Schedule I Correct Answer: This class/schedule of drugs have NO currently accepted medical use in treatment in the U.S,] A lack of accepted safety for use under medical supervision And a HIGH POTENTIAL FOR ABUSE False Correct Answer: True or false: a schedule I drug can be prescribed, administered or dispensed for medical use Heroin LSD Marijuana Peyote Methaqualone Ecstasy (methylene-dimethoxymethamphetamine) Correct Answer: What are examples of schedule I drugs Schedule II Correct Answer: This class/schedule of drugs have a currently accepted medical use in treatment in the US with severe restrictions, but have a HIGH potential for abuse with severe psychological or physical dependence Morphine Codeine Opium Methadone Hydromorphone Meperidine Oxycodone Fentanyl Correct Answer: What are some examples of schedule II drugs Amphetamine Methamphetamine Methyphenidate (Ritalin) Correct Answer: What are some examples of schedule II STIMULANTS Schedule III Correct Answer: This class/schedule of drugs have a currently accepted medical use in treatment in the US and have LESS potential for abuse than schedules I and II substances; may lead to MODERATE or LOW physical dependence BUT HIGH psychological dependence Verbal orders ok Refills ok, up to 5 refills in 6 months Partial fillings allowed Mandated daily sign off by the pharmacist verifying controlled substances dispensed that day Correct Answer: What are the guidelines for both schedule III and IV drugs Products not containing more than 90mg of codeine/dosage unit Non narcotics such as benzphetamine, dronabinol, and anabolic steroids (oxandrolone) Correct Answer: What are some examples of schedule III drugs Schedule IV Correct Answer: This class/schedule of drugs have a currently accepted medical use in treatment in the US and have A LOW potential for abuse relative to schedule III drugs. Abuse may lead to limited physical dependence or psychological dependence relative to schedule III drugs Propoxyphene Alprazolam Clonazepam Clorazepate Diazepam Lorazepam Midazolam Temazepam Triazolam Zolpidem Correct Answer: What are some examples of schedule IV drugs Schedule V Correct Answer: This class/schedule of drugs have a currently accepted medical use in the US and have a LOW potential for abuse; Abuse may lead to limited physical or psychological dependence. Consists primarily of preparations containing limited quantities of certain narcotic and stimulant drugs Generally used for antitussive, antidiarrheal, and analgesic properties Verbal orders ok Refills ok as authorized by prescriber (REFER TO STATE LAW FOR LIMITS FOR WHAT STATE YOU ARE STUDYING FOR) Partial fillings allowed Mandated daily sign off by the pharmacist verifying controlled substances dispensed that day Correct Answer: What are the guidelines for schedule V drugs Promethazine with codeine Robitussin AC Cough preparations containing no more than 200mg codeine per 100 ml Correct Answer: What are some examples of schedule V drugs It is a schedule V BUT must have a prescription written Correct Answer: What is special about Phenergan with codeine Pharmacy is licensed Correct Answer: A pharmacist without their own DEA # may dispense controlled substances IF Must be recorded Records filed separately Kept for 2 years Correct Answer: Every transaction where a controlled substance changes hands No refills, no expiration date Correct Answer: How many times can you refill a schedule II 5 refills in 6 months from the date prescription is written Correct Answer: Schedule III and IV - how many times can you refill and for how long Refills permitted as authorized by prescriber Correct Answer: How many times can you refill a schedule V DEA Form 41 Correct Answer: Documents disposal and destruction of scheduled drugs Yes; any quantity per US Postal regulations Correct Answer: Can prescription controlled substances by mailed by the pharmacist The first letter of the practitioner's last name Correct Answer: The 2nd letter of a DEA number is usually what Add 1st, 3rd and 5th digit Add 2nd, 4th and 6th digit and multiply by 2; add to the first sum Determine whether the right-most digit of the sum corresponds with the ninth placement (There are 2 letters and 7 numbers; the 7th number is a check digit Correct Answer: How do you figure out if a DEA number is legit DEA Registration Correct Answer: What is required by the DEA for "practitioners"? 1. Employees of registrants 2. Law enforcement 3. Certain military Correct Answer: Controlled substances must be under the control of someone registered, except What you are doing, not who you are Correct Answer: DEA registration is based on what P or R Correct Answer: The DEA number of a distributor begins with: A or B Correct Answer: The DEA number of a dispense begins with Manufacturer Distributor Dispenser Research Narcotic treatment program Exporter Chemical analysis Correct Answer: Separate DEA registration is required for If a narcotic is less than 20% of complete product Correct Answer: For a pharmacist, no manufacturing license is required if If the total number of dosage units distributed exceeds 5% of all controlled substances dispensed per calendar year Correct Answer: A pharmacy-distributor license is required if Symbol of CII, etc Clear and large enough to promptly identify Correct Answer: All controlled drugs must have this on the manufacturing label Report to DEA Report to local police Correct Answer: Federal controlled substance theft requires these two things They must be filed separately Correct Answer: What is the filing requirement of schedule II (and I per note cards?) A red-ink stamped C Correct Answer: What must be found in the lower right corner of all schedule Rxs They will NOT be found in a pharmacy Correct Answer: Will schedule I prescriptions ever be found in a pharmacy DEA Form 222 Correct Answer: -must be used whenever Sch I or II drugs are bought, sold or transferred between pharmacies or qualified distributors A working pharmacist must be granted power of attorney by a registrant Correct Answer: What is required of someone who may order and sign a DEA form 222 for schedule I and II The supplier of the drug Correct Answer: Who keeps copy 1 of the DEA form 222 The local DEA agent in charge of the area where the SUPPLIER is located Correct Answer: Who keeps copy 2 of the DEA form 222 The purchaser of the controlled substance Correct Answer: Who keeps copy 3 of the DEA form 222 Purchaser fills out DEA form 222 in triplicate Purchaser keeps copy 3 for their records and sends copy 1 and 2 to supplier Supplier keeps copy 1 for their records Supplier sends copy 2 to the local DEA agent in THEIR area (as in the SUPPLIER's area) Correct Answer: What is the paper trail for a DEA 222 Prescription Correct Answer: An order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to an ultimate user 2 years Correct Answer: How long must the files of schedule II (and I per note cards) be kept If electronically filed with special numbers assigned to controlled substances Correct Answer: No red-ink stamped C required if No Correct Answer: Is an order to dispense a drug to a bed patient in a hospital /LTAC for immediate administration in a hospital Code of Federal Regulations (CFR) - under the CSA Correct Answer: A codification of the rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR Correct Answer: Is reserved for the rules of the FDA and DEA Title 21 of the CFR Correct Answer: Regulations which provide specific requirements for the prescribing and dispensing of controlled substance prescriptions Agent Correct Answer: A representative of a prescriber authorized to communicate prescriptions on behalf of the prescriber NO Correct Answer: Can agents of a prescriber phone in emergency CII prescriptions Prepare a controlled substance prescription for the signature of the prescriber Orally communicate a prescrber's CIII, CIV, or CV prescription to a pharmacist Transmit, by fax, a prescriber's written CII prescription to a pharmacist (when permitted) Correct Answer: What can an agent of a prescriber do per Title 21 1. Authorized to prescribe controlled substances by the jurisdiction in which he licensed to practice AND 2. Either registered with the DEA or exempted from registration (ex. Public Health Service, Federal Bureau of Prisons, or Military Practitioners) OR 3. An agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution Correct Answer: Under Title 21 of the Code of Federal Regulations, a prescription for a controlled substance may be issued only by an individual practitioner who is: For a legitimate medical purpose by a practitioner acting in the usual course of his professional practice Correct Answer: To be valid, a prescription must be issued.... State Law, NOT by the DEA Correct Answer: The term "Legitimate Medical Purpose" is defined by ..... and not the________________ Oregon says its ok to prescribe lethal doses for suicide, the DEA says no but the state of Oregon won Correct Answer: Discuss Gonzales vs. Oregon in 2006 A written document Correct Answer: _______________________ must be created and must specify the parameters of the authority granted to the agent Corresponding Responsibility Doctrine Correct Answer: What rests with the pharmacist who fills the prescription even though the practitioner is responsible for the proper prescribing and dispensing of controlled substances under Title 21 Title 21 of the CFR Correct Answer: Corresponding responsibility of the pharmacist falls under what law 1. The prescriber writes significantly more Rxs (or in larger quantities) 2. The patient appears to be returning too frequently 3. The prescriber writes Rxs for the antagonistic drugs, such as depressants and stimulants, at the same time 4. Patient appears presenting Rxs written in the names of other people 5. A number of people appear simultaneously, or within a short time, all bearing similar Rxs from the same physician 6. Numberous people who are not regular patrons or residents of your community suddenly show up with Rxs from the same physician Correct Answer: Circumstances which are indicative prescription was not issued for a legitimate medical purpose 1. Rx looks "too good"; the prescriber's handwriting is too legible 2. Quantities, directions, or dosages differ from usual medical dosage 3. Prescription does not comply with the acceptable standard abbreviations or appear to be textbook presentations 4. Rx appears to be photocopied 5. Directions written in full with no abbreviations 6. Rx written in DIFFERENT COLOR inks or written in different handwriting 7. Apparent erasure marks Correct Answer: Characteristics of forged prescriptions would include: 1. Fill an Rx that is illegitimate 2. Fill an Rx for a doctor to dispense in his/her office 3. Fill an Rx for detox or maintenance Correct Answer: A pharmacist may not knowingly......(3 things) State law determines who is eligible to write prescriptions and is what, any limitations Correct Answer: Who may legally write an Rx for a controlled substance 1. Patient info (name, address) 2. Doctor info (signature, name, address, DEA #) 3. Prescription info (date of issue, name of drug, strength, dose form, quantity, directions, refills) Correct Answer: DEA mandated items on a controlled substance Rx includes: 1. May add or change patient's address upon verification 2. May add or change dosage form, drug strength, drug quantity, directions for use, or issue date ONLY AFTER consultation with and agreement of prescriber 3. Changes must be noted on the prescription Correct Answer: What changes may a pharmacist make to an Rx written for Schedule III-V controlled substances 1. Changes to patient's name 2. Controlled substance prescribed (except for generic substitution) 3. Prescriber signature Correct Answer: What changes are NEVER permitted to a controlled substance prescription State law determines what changes may be made to a CII prescription after oral consultation with the prescriber Correct Answer: What changes may a pharmacist make to an Rx written for schedule II controlled substance On 11/19/2007, in the preamble to the Final Rule entitled Issuance of Multiple Rxs for CII Controlled Substances, the DEA stated that "The essential elements of the CII prescription (i.e. name of the controlled substance, strength, dosage form, and quantity prescribed) MAY NOT BE MODIFIED ORALLY. This is in opposition to the DEA's previous policy which treated CII's like CV's Correct Answer: A DEA suffix Correct Answer: What are hospital interns assigned in order to prescribe controlled substances False - just written, except for exceptions Correct Answer: schedule II prescriptions can be written or verbal, no exceptions 1. Emergency supply - pt needs drug immediately; MD cannot get prescription to the pt or pharmacy; Schedule III will not alleviate pain 2. Rx reduced to writing and MD contacted - Rx must be mailed to RPh within 7 days OR RPh must notify the nearest office of the DEA 3. On the face of the prescription, it must say "AUTHORIZED FOR EMERGENCY DISPENSING" Correct Answer: What are exceptions to the rules regarding schedule II medications only being written Emergency period Correct Answer: Per Federal Law, quantity is limited to ____________________ in regard to an emergency prescription State law Correct Answer: Who may further define what and how long an emergency period is NO Correct Answer: Can a prescription for a controlled substance be written in pencil Ink, indelible pencil, or typewritten; must be signed in prescriber's own handwriting Correct Answer: What must a prescription be written with 1. For a schedule II substance to be compounded for the direct parenteral, IV, SC, IM, or intraspinal administration 2. LTCF- Long-term care facility 3. Patients enrolled in a Hospice program (prescriber MUST note on the Rx "FOR A HOSPICE PATIENT") Correct Answer: When are faxed prescriptions allowed to be kept as an original Rx (in place of a handwritten hard copy) for schedule II drugs? "FOR A HOSPICE PATIENT" Correct Answer: What must appear on a faxed prescription for a hospice patient if the prescription will be kept as an original? Chronically ill patients living at home Correct Answer: When are faxed prescriptions NOT allowed to be kept as an ORIGINAL RX (in place of a handwritten hard copy) for schedule II drugs Yes Correct Answer: If a vet called in an emergency prescription for a dog, prescribing a CII, can you legally fill it No Correct Answer: Does the CSA differentiate between human and animal prescription emergencies No - only the prescriber can call in the emergency class II Correct Answer: If a vet's assistant called in the emergency class II prescription instead of the vet, can you legally fill it Vermont Correct Answer: As of 9/15/15, what was the final state to legalize electronic prescriptions for all controlled substances The transmitting and receiving systems are CERTIFIED by an approved outside agency that meets the Federal Regulations Correct Answer: Federal Law allows for prescribers to transmit prescriptions electronically to a pharmacy, provided that ___________________ It is allowed if the pharmacist is unable to supply the full quantity, BUT THE BALANCE MUST BE FILLED WITHIN 72 HOURS OR THE BALANCE IS VOID Correct Answer: Partial filling of schedule II Rxs are allowed if____________ Comprehensive Addiction and Recovery Act of 2016 Correct Answer: What does CARA stand for A patient may request a partial fill and the pharmacist may fill the balance within the 30 days from the date it was written However, most states specifically prohibit partial fills of a CII Correct Answer: What does CARA of 2016 allow LTCF and patients who are terminally ill, may be filled in partial quantities to include individual dosage units, valid for 60 DAYS from issue date Correct Answer: What is the exception to the 72 hour rule Date filled Pharmacy name and address Rx number Name of patient Name of prescriber Directions Cautionary statements if required Correct Answer: What are the schedule II labeling requirements Not more than 7 day supply Not in possession of user Institution maintains safeguards and records Pharmacist employs some system to identify the supplier, the products, the patient,, directions, and cautions if needed Correct Answer: What are the exemptions to the schedule II labeling requirements 1. Permissible between pharmacies on a one-time basis only 2. Pharmacies which electronically share a real-time on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization 3. Transfer must be communicated directly between two licensed pharmacists 4. Transferring pharmacist must write "VOID" on face of prescription, include the name, address and DEA# of the pharmacy to which it was transferred and the name of the receiving pharmacist on the back 5. Receiving pharmacist must write "TRANSFER" on the face and record the information from the original Rx, number of refills left, name, address of pharmacy, DEA of pharmacy and name of the pharmacist who transferred the prescription Correct Answer: What are the rules of transferring schedule III-V controlled substances Pharmacist only Correct Answer: A schedule V - non prescription must be dispensed directly by whom Not more than 240ml/8oz of any controlled substance containing opium, nor more than 48 dosage units in any 48 hour period Not more than 120ml/4oz of any controlled substance containing another controlled substance, nor more than 24 dosage units in a 48 hour period Purchase must be at least 18 years old Identification required Bound record book kept: record item dispensed, quantity, purchaser name and address and initials of Rph Correct Answer: What rules apply to non prescription schedule V drugs 18 years old Correct Answer: How old must you be to purchase a non Rx schedule V prescription DEA, FDA, and SMA Correct Answer: Narcotic addiction programs must be approved by State Methadone Authority Correct Answer: What does SMA stand for Less than 30 days Correct Answer: How long is short term detox More than 30 days but less than 180 days Correct Answer: How long is long term detox Detoxification Correct Answer: Giving a narcotic drug in decreasing doses to offset withdrawal symptoms Maintenance Correct Answer: Dispensing stable dosage levels for heroin and morphine-like drug addiction Narcotic treatment program Correct Answer: An organization or person that administers or dispenses a narcotic to an addict and provides comprehensive medical and rehab Approved by state and FDA 1. Methadone 2. LAAM (Levo-Alpha-Acetyl-Methadol) 3. Buprenophrine/Naloxone (Suboxone) 4. Buprenoprhine (Subutex) Correct Answer: What 4 medications are approved for medical treatment of narcotic addiction FDA, DEA, and state Correct Answer: Who approves the medication unit Licensed practitioner (RPh, RN, LPN under direction of licensed practitioner) Correct Answer: Who may dispense rehab medications 3 years Correct Answer: How long must records be kept for maintenance programs DEA Correct Answer: Security and storage standards are established by whom True Correct Answer: True or false: only approved narcotic treatment programs may undertake maintenance treatment 180 days Correct Answer: What is the maximum number of days a hospital can maintain if a patient is verified to be enrolled in an approved narcotic treatment program When there is an imminent danger to the public health and safety Correct Answer: When can the Attorney General revoke a license Ensuring Patient Access and Effective Drug Enforcement Act of 2016 Correct Answer: A bill that was passed to help clarify points of the Controlled Substances Act and facilitate a greater collaboration between Federal entities and drug supply chains Imminent Danger to the Public Health and Safety Correct Answer: Due to failure of the registrant to maintain effective control against diversion or otherwise comply with the obligations of a registrant, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur IN THE ABSENCE of an IMMEDIATE SUSPENSION of the registration Violation Correct Answer: Companies who inadvertently violate the CSA to submit a corrective action plan to remediate the violation before their registration is suspended and the supply of drugs to patients is interrupted (What's the question?) Buprenorphine Correct Answer: What is Subutex Buprenorphrine /Naloxone Correct Answer: What is Suboxone The prescriber's regular DEA number and a DEA number that has an X indicating his ability to prescribe buprenorphine Correct Answer: What DEA numbers must be on a prescription for buprenorphine Physician gets a waiver through special circumstances or through 8 hours of addiction training Correct Answer: What must a prescriber do to be able to prescribe No more than 30 addictions the first year; then can apply to treat up to 100 addiction patients Correct Answer: How many patients can a physician treat Health Insurance Accountability and Accountability Act (HIPAA) of 1996 Correct Answer: What does HIPPA stand for Protecting patient information Allows patients to access their medical records and provide more control over how patient's personal health info is used and disclosed Correct Answer: What issues does HIPPA address April 14, 2013 Correct Answer: What date did HIPPA take effect even though it's dated 1996 1. The patient and anyone the patient authorizes to see his/her medical information 2. The physician who wrote the prescription and his/her office staff as needed 3. The pharmacist who filled the prescription and his/her office staff as needed 4. Any State Board of Pharmacy inspector Correct Answer: Who is entitled to see the information of a particular prescription Amendment for internet pharmacies Correct Answer: The Ryan Haight Online Pharmacy Consumer Protection Act, which amends the CSA, is an amendment for ___________________ 1. Face to face requirement for prescribing (MD must conduct one in-person medical evaluation of the patient) 2. Endorsement required before a pharmacy can dispense controlled substances 3. Enhanced penalties for unlawful dispensing of schedule III through V 4. Prohibition of advertising illegal sales 5. Must post certain information on their website: Location, identity, and licensure of the pharmacy, pharmacists, or prescribers in states in which they are authorized to practice pharmacy 6. State cause of action: gives power to state attorney general to shut down, not just stop sales but must give written notice to US attorney general Correct Answer: What are the ballet points of the Ryan Haight Online Pharmacy Consumer Protection Act Covering physician Correct Answer: Who may write a valid prescription at the request of a practitioner who has conducted an in-person or telemedicine examination within the previous 24 months and is temporarily unavailable to evaluate the patient US Attorney General, State Boards of Pharmacy; 30 days Correct Answer: For endorsement, an internet pharmacy must notify the ______________ and the___________________in any states where the online pharmacy offers to sell, deliver, distribute or dispense controlled substances at least ___________ prior to selling on the internet. Schedule III: contains not more than 90mg of codeine per dosage unit Correct Answer: Tylenol with codeine tablets are considered what schedule and why Schedule II: Contains not more than 15mg of dihydrocodeine per dosage unit Correct Answer: Tussionex suspension is considered what schedule and why Schedule IV: despite having a lower risk of dependence and fewer side effects than benzodiazepines which are also C-IV Correct Answer: Ambien is considered what schedule and why Schedule IV: trick question....dont confuse it with meperidine Correct Answer: Meprobamate Schedule III Correct Answer: Fiorinal butalbital/aspirin/caffeine; III Correct Answer: Fiorinal is composed of what 3 drugs and is what schedule Butalbital/APAP/Caffeine; AND IS NOT CONTROLLED Correct Answer: Fioricet is composed of what 3 drugs and is what schedule Trick question - wholesaler must fill out the DEA-222 form Correct Answer: If you want to return a CII item to the wholesaler, what form must you use? (You should ask Ed King) HIPPA Correct Answer: Kassebaum-Kennedy Act Department of Health and Human Services Correct Answer: Who came up with HIPPA True Correct Answer: True or false: An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a valid prescription and a pharmacist may NOT knowingly fill one. Mix with coffee grounds or cat litter and seal in a container Correct Answer: What do you do with unused medications to be disposed of that cannot be flushed The FDA on October 9, 2014 expanded pharmacy take-back programs to include controlled substances Previously patients had to dispose of themselves (by flushing or discarding), surrender them to law enforcement, or seek assistance from the DEA Correct Answer: What are the newest regulations regarding disposal of unwanted controlled substances Ephedrine, pseudoephedrine (PSE) and phenylpropanolamine Correct Answer: What 3 drugs are in the. CSA category of "scheduled listed chemical products" 3.6 gram per day Correct Answer: What are the daily limits on OTC salts of ephedrine, pseudoephedrine containing products 9 gram per 30 days Correct Answer: What is the monthly limit on OTC sales of ephedrine, PSE containing products Behind a counter or in a locked cabinet Correct Answer: Where should PSE or PPA or ephedrine products be kept Product name Quantity sold Names and addresses of purchasers Dates and times of sales Correct Answer: What information must be included in the logbook for sales of PSE, ephedrine products Present a photo ID and sign the logbook Correct Answer: What must the purchaser of PSE do when making a PSE purchase 7.5 gram per 30 days Correct Answer: What is the monthly MAIL ORDER limit on OTC sales of ephedrine, PSE containing products 7.5 gram per 30 days Correct Answer: What is the monthly limit for MOBILE SELLERS (rt kiosk) on OTC sales of ephedrine, PSE containing products Fentanyl Oxycodone Morphine Burprenorphine Hydrocodone Meperidine Tapentadol (NUCYNTA) Sodium Oxybate (XYREM) Hydromorphone Methylphenidate (DAYTRANA PATCH) Diazepam Methadone Oxymorphone (OPANA) Correct Answer: What are some examples of medications recommended to be disposed of by flushing in sink or toilet Drug take back programs Correct Answer: May be offered by states in order to safely dispose of unused medications PSE 240mg, loratadine 10mg Correct Answer: What is in Claritin-D 24 hour PSE 30mg, IBU 200mg Correct Answer: What is in Advil Cold and Sinus PSE 30mg Correct Answer: What is in Sudafed Congestion PSE 120mg Correct Answer: What is in Sudafed-12 hour PSE 120mg, Naproxen sodium 220mg Correct Answer: What is in Sudafed 12 hour Pressure and Pain PSE 240mg Correct Answer: What is in Sudafed 24 hour Levonorgestrel 1.5mg Correct Answer: What is in Plan B One step Plan B one step to be available to all women of reproductive potential WITHOUT A PRESCRIPTION Correct Answer: What did the FDA begin to allow on June 20, 2013 ELLA Correct Answer: What is the Rx version of the OTC Plan B One Step Must be taken orally within 5 days to prevent pregnancy Correct Answer: What are the directions for ELLA Man or woman Correct Answer: When the FDA says "individual", it means...... "Void" or "illegal" pantograph appears when Rx is photocopied Quantity check of boxes, chemically reactive paper, uniform, non white background color Bar codes, logos, heat sensing imprint, security features and descriptions listed on prescriptions Correct Answer: What 3 features must be on all prescription pads to be considered tamper resistant Unauthorized copying of a completed or blank prescription form The erasure of modification of information written on the prescription pad by the prescriber The use of counterfeit prescription forms Correct Answer: What is prevented by using tamper resistant prescription pads Tamper resistant prescription pads Correct Answer: Written prescriptions for Medicaid patients MUST be written on. ________________________________ Deficit Reduction Act of 2005 Correct Answer: Created Medicaid Integrity Program (MIP), which increased resources available to CMS to combat abuse, fraud, and waste in the Medicaid program. Congress requires annual reporting by CMS about the use and effectiveness of funds appropriated for the MIP. Deficit Reduction Act Correct Answer: What act do the tamper resistant prescription pad requirement fall under Drug Quality and Security Act of 2013 Correct Answer: FDA tracking system for bulk compounding supplies 503A and 503B Correct Answer: What are the two important sections of the Drug Quality and Security Act Traditional compounding pharmacy Utilizes a 3 party group (patient, prescriber, pharmacist) Leaves the state boards in charge of compounding (most using USP 795 and 797 as their standard) Correct Answer: What does section 503A discuss in the Drug Quality and Security Act Regarding facilities that compound in bulk Must voluntarily register with the FDA Must be compliant with GMPs Can be subject to FDA inspections Correct Answer: What does section 503B discuss in the Drug Quality and Security Act Each state authorizes who can prescribe medication, not regulated federally Correct Answer: Who can prescribe a medication Drug Supply Chain Security Act Correct Answer: Requirements for tracing prescription drug products through pharmaceutical supply distribution chain. A prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing, or the transfer of the product between persons in which a a change of ownership occurs Correct Answer: What does the Drug Supply Chain Security Act track OTCs Blood and blood components for transfusion Radioactive drug and radioactive biologics Imaging drugs Intravenous products Medical gas Compounded drugs Medical convenience kits and combination products Sterile water and products intended for irrigation Veterinary drugs Correct Answer: What products are exempted from the DSCSA Dispensing drugs pursuant to a prescription to fulfill a "specific patient need" for an identified patient Intracompany distribution of any products between members of an affiliate or within a manufacturer Distribution of a product among hospitals or other health care entities that are under common control Distribution of a product for Public Health Emergencies Manufacturer product samples Minimal quantities dispensed by a retail pharmacy to a physician clinic for office use Sale purchase or trade to an IRS defined charitable organization Saleable and non saleable returns Correct Answer: What are the transfer exemptions for the DSCSA March 1, 2016 Correct Answer: When was the DSCSA passed A breakaway seal is broken Correct Answer: How do you know an emergency kit has been opened or used Chain of custody Correct Answer: An emergency kit follows a ___________ of ______________ so that you always know who is responsible for it Pharmacy replaces the unsealed kit with a sealed kit Correct Answer: What does the pharmacy do when an emergency kit is used Yes -like morphine in an emergency kit for a heart attack patient Correct Answer: Can an emergency kit contain a narcotic and give an example It is done just like in hospitals. Orders are written by the prescriber in the patient's chart and it is sent to the pharmacy Correct Answer: How does a physician write a prescription for a patient in a Long Term Care Faciltiy (LTCF)